These highlights do not include all the information needed to use SPRITAM® safely and effectively. See full prescribing information for SPRITAM.
SPRITAM (levetiracetam) tablets, for oral suspension
Initial U.S. Approval: 1999
RECENT MAJOR CHANGES
Warnings and Precautions, Hematologic Abnormalities (5.8) 03/2018
INDICATIONS AND USAGE
SPRITAM is indicated for adjunctive therapy in the treatment of:
Partial onset seizures in patients with epilepsy 4 years of age and older weighing more than 20 kg (1.1)
Myoclonic seizures in patients 12 years of age and older with juvenile myoclonic epilepsy (1.2)
Primary generalized tonic-clonic seizures in patients 6 years of age and older with idiopathic generalized epilepsy (1.3)
DOSAGE AND ADMINISTRATION
SPRITAM is intended to disintegrate in the mouth when taken with a sip of liquid. Swallow only after the tablet disintegrates. Do not swallow tablet(s) intact. Partial tablet(s) should not be administered (2.1)
Alternately, add whole SPRITAM tablet(s) to a small volume of liquid in a cup (one tablespoon or enough to cover the medicine). Allow the tablet(s) to disperse prior to consuming entire contents immediately (2.1)
Partial Onset Seizures
Adults/pediatric patients 4 years and older weighing over 40 kg: 500 mg twice daily; increase as needed/tolerated by 500 mg twice daily every 2 weeks to a maximum recommended dose of 1500 mg twice daily (2.2)
Pediatric patients 4 years and older weighing 20 to 40 kg: 250 mg twice daily; increase by 250 mg twice daily every two weeks to a maximum of 750 mg twice daily (2.2)
Myoclonic Seizures in Adults and Pediatric Patients 12 Years of Age and Older
500 mg twice daily; increase by 500 mg twice daily every 2 weeks to recommended dose of 1500 mg twice daily (2.3)
Primary Generalized Tonic-Clonic Seizures in Patients 6 Years of Age and Older
Adults/pediatric patients 6 years and older weighing over 40 kg: 500 mg twice daily; increase as needed/tolerated by 500 mg twice daily every 2 weeks to a maximum recommended dose of 1500 mg twice daily (2.4)
Pediatric patients 6 years and older weighing 20 to 40 kg: 250 mg twice daily; increase by 250 mg twice daily every 2 weeks to a maximum of 750 mg twice daily (2.4)
Adult Patients with Renal Impairment
Dose adjustment is recommended based on creatinine clearance (2.5, 8.6)
DOSAGE FORMS AND STRENGTHS
Tablets for oral suspension: 250 mg, 500 mg, 750 mg, and 1000 mg (3)
CONTRAINDICATIONS
Known hypersensitivity to levetiracetam; angioedema and anaphylaxis have occurred (4)
WARNINGS AND PRECAUTIONS
Behavioral Abnormalities: psychotic symptoms, irritability, and aggressive behavior have been observed: Monitor for signs and symptoms (5.1)
Suicidal Behavior and Ideation: Monitor for new or worsening depression, suicidal thoughts/behavior, and/or changes in mood or behavior (5.2)
Monitor for somnolence and fatigue and advise patients not to drive or operate machinery until they have gained experience on SPRITAM (5.3)
Withdrawal Seizures: SPRITAM must be gradually withdrawn (5.7)
ADVERSE REACTIONS
Most common adverse reactions (incidence ≥ 5% more than placebo) include:
Adults: somnolence, asthenia, infection, and dizziness (6.1)
Pediatrics: fatigue, aggression, nasal congestion, decreased appetite, and irritability (6.1)
To report SUSPECTED ADVERSE REACTIONS, contact Aprecia Pharmaceuticals, LLC at 1-844-882-7732 or FDA at 1-800-FDA-1088 or www.fda.gov/medwatch.
USE IN SPECIFIC POPULATIONS
Pregnancy: Plasma levels of levetiracetam may be decreased and therefore need to be monitored closely during pregnancy; based on animal data, may cause fetal harm (5.10, 8.1)
See 17 for PATIENT COUNSELING INFORMATION and Medication Guide.
Revised: 9/2018
